(114 days)
The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional Combined Spinal Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for insertion into the spinal and epidural space, as well as catheter placement into the epidural space to facilitate a longer anesthetic effect. After the anesthesia conduction needle has been withdrawn from the patient, the cather tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
Pajunk's EpiSpin set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a Combined Spinal-Epidural (CSE) anesthesia kit consisting of two needles, one for insertion into the epidural space (a specialized Tuohy Cannula) and one for insertion into the spinal space (a Sprotte Cannula). This needle through-needle technology is accomplished using an aperture in the curved tip of the specialized Tuohy Cannula (called the "backeye"), for advancement of the Sprotte Cannula into the spinal space. The Spinal needle does not bend at all, but passes easily thru the Tuohy needle. There is no significant friction of metal against metal involved at all.
The provided document is a 510(k) Premarket Notification Submission for the EpiSpin Anesthesia Conduction Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive independent clinical study data with acceptance criteria and performance metrics typically seen for novel devices.
Therefore, the document does not contain specific acceptance criteria, comprehensive study results proving device performance against those criteria, or the detailed information on study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies) that you requested.
The document primarily focuses on:
- Device Description: What the EpiSpin set is and its components.
- Predicate Devices: Identifying previously cleared devices to which the EpiSpin kit claims substantial equivalence.
- Sterilization: Details about the sterilization process.
- Technological Characteristics: How the device works (needle-through-needle technology).
- Indications for Use: The intended applications for the EpiSpin kit and its individual components (LOR-Syringe, Fixolong, Flat Filter, Tuohy Borst Adaptor, Anesthesia conducting Catheter).
- Substantial Equivalence Conclusion: A statement that the device is safe, effective, and substantially equivalent to the predicate devices.
- FDA Clearance Letter: Confirmation of FDA's substantial equivalence determination.
Key Missing Information for your request:
- Acceptance Criteria Table and Reported Device Performance: This document does not present specific quantitative acceptance criteria or detailed performance data against them. The "proof" of meeting criteria is typically the claim of substantial equivalence to existing devices that have already met such criteria.
- Sample sizes for test set and data provenance: No dedicated clinical studies with test sets are described. The equivalence is based on design and material similarity and performance comparison to predicate devices, not on new clinical trials with specified sample sizes.
- Number and qualifications of experts for ground truth: No such experts are mentioned for a new study.
- Adjudication method: Not applicable as no new test set is described.
- MRMC comparative effectiveness study: No such study is mentioned or provided.
- Standalone algorithm performance: This is a physical medical device, not an AI algorithm, so standalone performance in that context is not relevant.
- Type of ground truth used: No new ground truth is established for efficacy in this submission; the basis is substantial equivalence to legally marketed devices.
- Sample size for training set and how ground truth was established for training set: These concepts are not applicable to the type of premarket notification presented for this physical medical device.
In summary, the provided document does not contain the detailed study information you are requesting because it is a 510(k) submission focused on demonstrating substantial equivalence, not on presenting novel clinical trial data with specific acceptance criteria and performance metrics.
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EpiSpin Premarket Notification Submission
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510(k) Premarket Notification Submission:
JUN - 2 2006
Summary of Safety and Effectiveness
Date of Preparation: December 1, 2005
Submitter Information/ production site:
Sterilizer:
Pajunk GmbH Medizintechnologie Karl-Hall-Straße 01 78187 Geisingen Germany Fon: +49(0)7704-9291-533 Fax: +49(0)7704-9291-605
SteriPro Lab & EO Facility Dreieichstrasse. 7 64546 Mörfelden Germany Tel +49 6105 23091 or +49 (0) 6105 93470 Fax +49 6105 24760
Contact:
Christian Quaß, Regulatory Affairs Fon: +49(0)7704-9291-533 Fax: +49(0)7704-9291-605 E-Mail: christian.quass@pajunk.com Establishment Registration Number: 9611612
Device Information:
| Trade Names: | EpiSpin, EpiSpin Set, EpiSpin II Safety Kit |
|---|---|
| Common Name: | Anesthesia Conduction Kit |
| Classification Name: | Anesthesia Conduction Kit |
| Classification Reference: | 21 CFR § 868.5140, April 1, 2005, |
| Proposed Classification: | Regulatory Class II |
| Proposed Product Classification Code: | CAZ, Kit, Conduction Anesthesia |
| Panel: | Anesthesiology |
| Predicate Devices: | 1. Pajunks Stimulong Plus Plexus Catheter K043130, K0330182. Pajunks Plexolong Sets K042979, K023218, K0130413. Pajunk Sprotte and various Anesthesia conduction cannulas K040965, K911202, K911260, K9112214. BBrauns Espocan K932400 (including BBrauns Perifix K813186) |
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Image /page/1/Picture/1 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is in large, bold, white letters against a black background. Below this, the word "MEDIZINTECHNOLOGIE" is written in smaller, white letters.
Device Description:
Pajunk's EpiSpin set is a single use, sterile, non-pyrogenic and latex free medical device kit. It is a Combined Spinal-Epidural (CSE) anesthesia kit consisting of two needles, one for insertion into the epidural space (a specialized Tuohy Cannula) and one for insertion into the spinal space (a Sprotte Cannula). This needle through-needle technology is accomplished using an aperture in the curved tip of the specialized Tuohy Cannula (called the "backeye"), for advancement of the Sprotte Cannula into the spinal space. The Spinal needle does not bend at all, but passes easily thru the Tuohy needle. There is no significant friction of metal against metal involved at all.
Predicate Devices:
The devices we claim substantial equivalence with are Pajunks Stimulong Plus Plexus Catheter cleared under K043130, K033018, Pajunks Plexolong Sets cleared under K042979, K023218, K013041 for the whole Kit and cleared kit components and BBrauns Espocan K932400 (including BBrauns Perifix K813186) especially for the Kit components Tuohy Back-Eye and the LOR-Syringe as well as the intended use of the whole Kit.
The detailed discussion of substantial eqivalence can be found in Section 12 of this submission.
Sterilization
The contract sterilizer and the sterilizing process other than a company name change (was IBA Griffith Micro Science, and now is Sterigenics) is the same as that used for anesth esia conduction cannulae cleared for market by FDA under 510(k) number K040965 and Kit Products Pajunks Stimulong Plus Plexus Catheter K043130, K033018 Pajunks Plexolong Sets K1042879, K023218, K013041.
Technology Characteristics:
The EpiSpin kit provides needle-through-needle technology, employing the use of a Tuohy Cannula featuring a backeye, through which a Sprotte Cannula can be inserted in the spinal space for immediate administration of spinal anesthesia. The Sprotte Cannula is then removed, and the epidural catheter is then placed for prolonged (up to 72 hours) administration of epidural anesthesia. Safety is optimized by the use of the catheters fixation adapter, Tuohy-Borst adapter, flat filter, Fixolong catheter fixation device, and optional Introducer Aid provided in the kit.
Conclusion:
The comparison between the predicate devices and the proposed devices in section 12 of this submission demonstrates that the proposed devices are safe and effective, as well as substantially equivalent to the predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 2006
Mr. Christian Quass Regulatory Affairs Pajunk GmbH Medizintechnologie Karl-Hall-Strasse 01 78187 Geisingen GERMANY
Re: K060563
Trade/Device Name: EpiSpin Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 19, 2006 Received: May 22, 2006
Dear Mr. Quass:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Quass
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and inoments as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K060563 510(k) Number:
Device Name: LOR-Syringe
Indications for Use:
The Pajunk Loss of Resistance (LOR)-Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks.
These syringes are not intended for injection or aspiration.
Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801.109)
(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Auy safiom
(off)
Anesthesiology, General Hospital,
on Control, Dental Devices
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Image /page/5/Picture/1 description: The image shows the logo for PAJUNK Medizintechnologie. The word "PAJUNK" is written in large, bold, white letters on a black background. Below the word "PAJUNK" is the word "MEDIZINTECHNOLOGIE" written in smaller, white letters.
K060563 510(k) Number:
Fixolong Fixation device Device Name:
Indications for Use:
The Pajunk Fixolong is an adhesive disk with catheter clips and flat filter attachment point on top. It is employed for fixing the catheter during long term anesthesia conduction.
The adhesive is hypo-allergenic and prevents accidental removal of epidural catheter. The catheter fastening clips allows stabilization of epidural catheter and prevents accidental movement. On the top there is an attachment site for flat filter to protect fixation
Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ainy Dalton
nesthesiology, General H
: Number: K0601
Page 1 of 1
01 :
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510(k) Number: K060563
Device Name: Flat Filter
Indications for Use:
The Pajunk anesthesia conduction flat filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sa த்துட்-Cit) on Signeral | General Hospital, . ان ان , Dental Devices
Amy Saloom
of Anas lesiology, General Hospital,
John Control, Lental De
Page 1 of 1
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Indications for use K060563 510(k) Number: Tuohy Borst Adaptor Device Name: Indications for Use: The Pajunk Tuohy Borst Adaptor is connected to the needle via Luer connector. It ensures The I agains Tuony Doroth laster is common of a Luer Lock syringe or infusion device. Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Aury Suliom
g. Off
ion of Anesthesiology, General Hospital,
ion Control, Dental Devices
Number: K060563
Page 1 of 1
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Indications for use
510(k) Number:
Device Name:
EpiSpin Kits for Anesthesiology
Indications for Use:
The Pajunk EpiSpin anesthesia conduction kit is indicated for administration of regional The Pagain Epidural (CSE) anesthesia. The anesthesia conduction needle is intended for Combined opinal Lpharrir (002) and epidural space, as well as catheter placement into the epidural space to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the cather tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
AND/OR
Over-The-Counter Use_ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amy Solomon
1 .. 45-011) n of Anesthesiology, I .on Control. Dental D
Number: K060563
Page 1 of 1
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510(k) Number: K060563
Device Name:
Anesthesia conducting Catheter
Indications for Use:
The Pajunk catheter is placed in the epidural space to facilitate a longer anesthetic effect.
After the anesthesia conduction needle has been withdrawn from the patient, the catheter tip can remain in the epidural space for as long as determined by the professional anesthetist and the instructions for use (up to 72 hours).
Prescription Use X
(Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Auu Suicom
i Anesthesiology, General Hospital on Control. De
CQ
PMN ADD
..
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).